Placing sutures

ABSTRACT

A suturing instrument including multiple needle and suture assemblies that are at least partially disposed within the suturing instrument allows a surgeon to place multiple sutures intercorporally without having to remove the instrument from a surgical site and reload the instrument between placing each suture. The suturing instrument includes an elongate body member that includes a distal portion defining an opening. The suturing instrument further includes a first needle disposed within the opening, a second needle disposed within the opening, and a needle deployment mechanism disposed at least partially within the elongate body member and connectable sequentially to the first needle and the second needle.

TECHNICAL FIELD

The invention relates to devices and methods for placing sutures.

BACKGROUND INFORMATION

Suturing of body tissue is a time consuming aspect of many surgicalprocedures. For many surgical procedures, it is necessary to make alarge opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

Some surgical instruments used in endoscopic procedures are limited bythe manner in which they access the areas of the human body in need ofrepair. In particular, the instruments may not be able to access tissueor organs located deep within the body or that are in some wayobstructed. Also, many of the instruments are limited by the way theygrasp tissue, apply a suture, or recapture the needle and suture.Furthermore, many of the instruments are complicated and expensive touse due to the numerous parts and/or subassemblies required to make themfunction properly. Suturing remains a delicate and time-consuming aspectof most surgeries, including those performed endoscopically.

Many medical procedures require that multiple sutures be placed within apatient. Typical suturing instruments enable a surgeon to place only onesuture at a time. With such suturing instruments, the surgeon isrequired to remove the instrument from a surgical site and reload theinstrument between placing each suture. Further, the surgeon may berequired to use forceps or other instruments to help place the suture.In some instances, the forceps or other instruments may require anadditional incision to access the surgical site.

SUMMARY OF THE INVENTION

The invention generally relates to a suturing instrument that can housemultiple needle and suture assemblies. The suturing instrument allows asurgeon to place multiple sutures without having to reload theinstrument after each suture is placed, which is more efficient and lessinvasive than a procedure where the surgeon has to remove the instrumentfrom the surgical site to reload. This is particularly helpful when thesurgical site is located deep within a body and not easily repeatablyaccessible.

In one aspect, the invention is directed to a suturing instrumentincluding an elongate body member, a first needle, a second needle, anda needle deployment mechanism. The elongate body member includes adistal portion that defines an opening. The first needle and the secondneedle are disposed within the opening. The needle deployment mechanismis at least partially disposed within the elongate body member and isconnectable sequentially to the first needle and the second needle. Theneedle deployment mechanism moves the first needle and then the secondneedle out of the opening.

In various embodiments, the distal portion may further define a tunnelin communication with the opening. The tunnel may be disposed adjacentthe opening, and the second needle and/or additional needles may bedisposed within the tunnel. The suturing instrument may also include aneedle catch disposed on the distal portion of the elongate body member.The needle catch is configured to receive the first needle and thesecond needle. The suturing instrument may also include a third needledisposed within the opening and connectable to the needle deploymentmechanism. In one embodiment, the needle deployment mechanism includes aneedle carrier and an actuator coupled to the needle carrier. The needlecarrier may be disposed at least partially within the opening and theactuator may be disposed in a proximal portion of the elongate bodymember. The needle carrier may include a distal portion that defines alumen for receiving at least one of the first needle and the secondneedle. The distal portion of the needle carrier may further define aslot in communication with the lumen for loading a suture.

In other embodiments, the second needle transitions from the opening tothe lumen after the first needle is deployed from the elongate bodymember. The first needle and second needle may each include a distalportion and a suture attached thereto. The opening may include a bottomsurface defining a slot for loading a suture. In additional embodiments,the elongate body member includes one or more bends. The suturinginstrument can be adapted to access remote organs or tissue within abody. The distal portion of the elongate body member may be rotatablerelative to a remainder of the elongate body member. Further, thesuturing instrument may include a handle disposed opposite the distalportion of the elongate body member. The handle can at least partiallyhouse the needle deployment mechanism. The suturing instrument can beused, for example, to access areas within the patient's body to ligate,fixate, or approximate tissue.

These and other objects, along with advantages and features of thepresent invention herein disclosed, will become apparent throughreference to the following description, the accompanying drawings, andthe claims. Furthermore, it is to be understood that the features of thevarious embodiments described herein are not mutually exclusive and canexist in various combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings, in which:

FIG. 1A is a schematic plan view of one embodiment of a suturinginstrument in accordance with the invention;

FIGS. 1B and 1C are schematic cross-sectional views of a proximalportion and a distal portion of the suturing instrument of FIG. 1A;

FIG. 2A is an enlarged cross-sectional view of the distal portion of thesuturing instrument of FIG. 1A;

FIG. 2B is a schematic top view of the suturing instrument of FIG. 2Ataken at line B-B;

FIG. 3A is a schematic plan view of a needle coupled to a suture for usein a suturing instrument in accordance with the invention;

FIG. 3B is a schematic perspective view of a needle catch for use withthe suturing instrument of FIG. 1A;

FIG. 4A-4E are partial schematic cross-sectional views of the distalportion of the suturing instrument of FIG. 1A during various operationalphases;

FIG. 5A is a partial schematic cross-sectional view of a distal portionof a suturing instrument in accordance with another embodiment of theinvention; and

FIG. 5B-5F are partial schematic perspective views of the distal portionof the suturing instrument of FIG. 5A.

DESCRIPTION

FIG. 1A depicts a suturing instrument 100 including a handle 102, anelongate body member 104, and a needle deployment mechanism 110. Thesuturing instrument 100 also includes a distal portion 106 and aproximal portion 108. The elongate body member 104 is mechanicallycoupled to the handle 102 at the proximal portion 108 and the suturingcomponents are ate least partially disposed within the distal portion106 of the suturing instrument 100.

The handle 102 could take a variety of forms, for example, the handle102 could be one of the types used with Boston Scientific Corporationsuturing systems, in particular the Capio® Push & Catch suturing system.Generally, the needle deployment mechanism 110 extends longitudinallythrough the elongate body member 104 to the distal portion 106 of thesuturing instrument 100, where the needle deployment mechanism 110 iscoupled to a needle 128 (FIG. 3A). The needle deployment mechanism 110moves the needle 128 between a retracted position and a deployedposition. The needle deployment mechanism 110 is shown in greater detailin FIGS. 1B and 1C.

Referring to FIG. 1B, the proximal portion 108 of the suturinginstrument 100 includes the handle 102, the elongate body member 104, asuture clip 144, and the needle deployment mechanism 110. The sutureclip 144 may be coupled to the handle 102 or the elongate body member104 and is used to hold an end of one or more sutures prior to placementin a patient. The needle deployment mechanism 110 includes an actuator112 (button 117, shaft 116), a bearing 118, a button end 119, and a hole121. The bearing 118 rides along a cylindrical surface 105 that isformed by the inside diameter of the elongate body member 104. Awireform 103 is inserted into the hole 121, coupling it to the actuatorbutton 117. A spring 115 encircles the wireform 103, abuts the buttonend 119, and is compressed between the button end 119 and a springwasher 113. The spring washer 113 is seated upon a center tube 107. Thecenter tube 107 is housed by the cylindrical surface 105 and isconstrained in the distal portion 106. A pusher wire 111 is attached tothe wireform 103 by means of a weld, a coupling, adhesive or othermeans, and is slidably disposed within a guidance sleeve 109, the sleeve109 being disposed within a cylindrical surface 123 formed by the insidediameter of the center tube 107. In one embodiment, the pusher wire 111is constructed of nitinol, so chosen for its combination of propertiesthat allow for bendability and high column strength when constrained.Nitinol is a nickel-titanium alloy.

Referring to FIG. 1C, the distal portion 106 of the suturing instrument100 of FIG. 1A includes the elongate body member 104, the needledeployment mechanism 110, an articulation mechanism 114, a curvedportion 126, and a needle catch 122. Referring again to the needledeployment mechanism 110, the pusher wire 111 is attached by welding orother means to a coupling 150, which is slidably disposed within a track152. The coupling 150 is attached to a carrier wire 154, which by virtueof its attachment to the coupling 150 is also slidably disposed withinthe track 152. The carrier wire 154 is mechanically coupled to anextendable needle carrier 124 by means of a weld, a coupling, adhesives,or other means. The coupling 150 abuts a backstop washer 156 that isslidably disposed about the pusher wire 111 and is contained within apocket 160 that includes a back wall 162, against which the backstopwasher 156 rests. The track 152 terminates distally in a pocket 164 thatincludes a wall 166. A downstop washer 158 is slidably disposed aboutthe carrier wire 154 and constrained within the pocket 164.

In some embodiments, the suturing instrument 100 may include thearticulation mechanism 114. The articulation mechanism 114 is disposedin the elongate body member 104 proximate the distal portion 106 (FIG.1C). The articulation mechanism 114 facilitates the rotation (in thedirections indicated by arrow 182) and positioning of the distal end 106of the suturing instrument 100. In addition, the elongate body 104 canbe substantially linear or may include one or more bends. Thearticulation mechanism 114 and/or bend(s) can facilitate access to deepand/or difficult to reach areas within the patient.

Referring to FIGS. 2A and 2B, the curved portion 126 defines a channel178, an opening (or needle exit port 120) including a tunnel or (needlecompartment 140), a needle input/output slot 142, and a suture slot 146.The curved portion 126 also defines an opening 176 for receiving tissue(FIG. 1C). The curved portion 126 also includes a knot pusher 184. Theneedle carrier 124 is disposed within the channel 178 in the curvedportion 126. A distal portion 180 of the needle carrier 124 defines alumen 138 for holding a needle 128 a, 128 b, or 128 c (generally needle128).

Referring to FIG. 3A, in one embodiment, the needle 128 includes a tip130 and a shaft 134 coupled to the tip 130, thereby forming a shoulder132. The shaft 134 is coupled to a suture 136 a, 136 b, 136 c (generallysuture 136). The needle 128 is inserted into the lumen 138 and held by aslight friction fit. The suture 136 extends out of a needle carriersuture slot 148 and the suture slot 146. Needles 128 b and 128 c arestored in the needle compartment 140 prior to being deployed.

Referring again to FIGS. 1B, 1C, 2A, and 2B, in operation, a user (suchas a physician or other medical personnel) actuates the needledeployment mechanism 110 by pushing on the button 117, which via theattachment to the wireform 103 which is attached to the pusher wire 111,moves the coupling 150 along the track 152 concomitantly moving thecarrier wire 154, which slidably moves the needle carrier 124 throughthe needle exit port 120. The user continues to push the button 117until the needle 128 enters the needle catch 122. The needle catch 122,as shown in FIG. 3B, includes openings 170 defined by successive ribs172. The needle catch 122 receives the needle 128 (coupled to the suture136) through opening 170, the ribs 172 deflect slightly to allow theneedle 128 to pass through. After the formed shoulder 132 has passed theribs 172, the ribs 172 spring back to their original position definingthe openings 170, and the needle 128 remains captured in the needlecatch 122. The user releases the button 117 and the spring 115 urges thebutton 117 proximally, moving the pusher wire 111, the coupling 150, thecarrier wire 154, and the needle carrier 124 proximally along with thebutton 117 to the retracted position. As the needle carrier 124 movesback to the retracted position, the needle 128 slides out of the lumen138. The openings 170 are chosen to be smaller in dimension than theformed shoulder 132. This causes the needle catch 122 to retain theneedle 128 because the flat rear surface of the shoulder 132 preventsthe needle 128 from passing back through the opening 170. When it isnecessary to remove the needle 128 from the needle catch 122, the needle128 may be moved toward an enlarged portion 174 of opening 172. Theenlarged portion 174 is sized to allow the formed shoulder 132 to passthrough without resistance. The needle catch 122 is preferablyconstructed of thin stainless steel of high temper, such as ANSI 301full hard. The needle catch 122 may be fabricated by means of stamping,laser machining, or chemical etching.

The suturing instrument's component materials should be biocompatible.For example, the handle 102, the elongate body member 104, and portionsof the needle deployment mechanism 110 may be fabricated from extruded,molded, or machined plastic material(s), such as polypropylene,polycarbonate, or glass-filled polycarbonate. Other components, forexample the needle 128, may be made of stainless steel. Other suitablematerials will be apparent to those skilled in the art. The material(s)used to form the suture should be biocompatible. The surgeon will selectthe length, diameter, and characteristics of the suture to suit aparticular application. Additionally, the mechanical components andoperation are similar in nature to those disclosed in U.S. Pat. Nos.5,364,408 and 6,048,351, each of which is incorporated by referenceherein in its entirety.

Referring to FIGS. 2A-2B and 4A-4E, the present invention enables a userto place multiple sutures 136 in a patient without removing the suturinginstrument 100 from the patient. The user loads the suture 136 c throughthe first suture slot 146 a until the suture 136 c emerges from thesecond suture slot 146 b. The user then inserts the needle 128 c throughthe needle input/output slot 142 into the needle compartment 140. Theuser repeats this process for additional sutures 136 and needles 128.The user can repeat this process for loading the first suture 136 a andthe first needle 128 a, or the user can insert the first needle 128 adirectly into the needle carrier 124. In either case, the sutures 136 a,136 b, 136 c extend out of the second suture slot 146 b. If the needle128 a is loaded into the needle compartment 140, the user pulls on thefirst suture 136 a (held by the suture clip 144) to cause the firstneedle 128 a to slide down an inclined needle shelf 204 and out of theneedle compartment 140 through the needle output slot 142 into the lumen138 of the needle carrier 124. The suture 136 a extends out of theneedle suture slot 148 and the second suture slot 146 b.

In another embodiment, the suture 136 a could be pulled by attaching thesuture 136 a to a spool mounted on the elongate body member 104 andwinding the spool. In still other embodiments, the suture 136 a could bepulled by other mechanical means known in the art, such as by a lever,for example. After the needles 128 a, 128 b, 128 c and sutures 136 a,136 b, 136 c are loaded into the suturing instrument 100, portions ofthe sutures 136 a, 136 b, 136 c extending out the suture slot 146 b areheld by the suture clip 144 (FIG. 1B). The needle carrier 124, which ispart of the needle deployment mechanism 110, is sequentially connectableto the needles 128 stored in the needle compartment 140. This means thateach needle 128 stored in the needle compartment 140 is connected to,and then deployed by, the needle carrier 124 one at a time in the orderthe needles 128 are dispensed from the needle compartment 140.

The user then inserts the elongate body member 104 into a patient andorients the elongate body member 104 so that the needle exit port 120 isproximate to or in contact with the tissue 206 to be sutured. The userthen pushes the button 117 (FIG. 1B), as described above. Pushing thebutton 117 causes the needle carrier 124 (holding the first needle 128a) to extend out of the needle exit port 120 and push the needle 128 athrough the tissue 206. As the first needle 128 a is pushed through thetissue 206, the first needle 128 a pulls the first suture 136 a throughthe tissue 206. As the user continues to push the button 117, the needlecarrier 124 continues to advance out of the needle exit port 120 anddirects the first needle 128 a and the first suture 136 a toward theneedle catch 122. The user continues to push the button 117 until thefirst needle 128 a contacts and becomes captured by the needle catch 122(FIG. 4B). The user then retracts the needle carrier 124 by releasingthe button 117, as previously described.

After the user retracts the needle carrier 124, the first needle 128 aand the first suture 136 a are left captured within the needle catch122, with the first suture 136 a extending through the tissue 206 (FIG.4C). When the needle carrier 124 returns to a fully retracted position,the user pulls on the second suture 136 b to cause the second needle 128b to slide down the inclined needle shelf 204 and out of the needlecompartment 140 through the needle input/output slot 142 and into thelumen 138 of the needle carrier 124. The second suture 136 b extends outof the needle carrier suture slot 148 and the second suture slot 146 b.The user then advances the needle carrier 124 as described above untilthe second needle 128 b is captured by the needle catch 122 (FIG. 4D).The user then retracts the needle carrier 124 as described above leavingthe second needle 128 b and the second suture 136 b captured by theneedle catch 122 (FIG. 4E). This procedure can be repeated for the thirdneedle 128 c, or for as many needles as may be stored in the needlecompartment 140.

After one or more sutures 136 have been placed, the user withdraws thesuturing instrument 100 from the patient. The user detaches thesuture(s) 136 from the needle(s) 128 and ties a knot or knots into thesuture(s) 136. The user can then use the knot pusher 184 to push theknot(s) into the patient as the knot(s) is tightened.

Referring to FIGS. 5A-5F, in an alternative embodiment, the distalportion 106 of the suturing instrument 100 includes a curved portion200. The curved portion 200 defines a needle compartment 188, a needleoutput slot 190, a needle loading slot 192, a first suture slot 196(FIG. 5B), and a second suture slot 198. In this embodiment, a needle128 a is inserted into the needle carrier 124 with a suture 136 aextending through the needle carrier suture slot 148, the first sutureslot 196 and the second suture slot 198. An additional needle 128 b isinserted into the needle compartment 188 through the needle loading slot192 with a suture 136 b-extending through the first suture slot 196 andthe second suture slot 198 (FIG. 5B).

In operation, this alternative embodiment functions largely the same wayas the embodiment previously described. The user advances the needlecarrier 124 by pressing the button 117 (FIG. 1A) until the first needle128 a along with the first suture 136 a is driven through the tissue andcaptured by the needle catch 122 (FIG. 5D). After the needle 128 a andthe suture 136 a are captured in the needle catch 122, the needlecarrier 124 is retracted so that the second needle 128 b can be loadedinto the needle carrier 124 (FIG. 5E). When the needle carrier 124 isfully retracted, the user pulls the second suture 136 b causing thesecond needle 128 b to slide into the needle carrier 124 from the needlecompartment 188 through the needle loading slot 190. The user againadvances the needle carrier 124 out of the needle exit port 120, throughthe tissue, and into the needle catch 122 (FIG. 5F). The user thenretracts the needle carrier 124 leaving the needle 128 b and coupledsuture 136 b captured by the needle catch 122. In other embodiments,more needles 128 and sutures 136 can be loaded into the needlecompartment 188.

Other embodiments incorporating the concepts disclosed herein may beused without departing from the spirit and scope of the invention. Thedescribed embodiments are to be considered in all respects as onlyillustrative and not restrictive.

1.-14. (canceled)
 15. A suturing instrument comprising: an elongate bodymember including a distal portion defining a needle compartment forstoring at least two needles; a needle deployment mechanism disposed atleast partially within the elongate body member, the needle deploymentmechanism including a needle carrier that is sequentially connectable tothe at least two needles; and a needle catch for sequentially receivingand capturing the at least two needles.
 16. The suturing instrument ofclaim 15 wherein each of the at least two needles has a suture attachedthereto.
 17. The suturing instrument of claim 15 further comprising ahandle disposed opposite the distal portion of the elongate body member.18. The suturing instrument of claim 15 wherein the elongate body memberis adapted to access organs or tissue within a body of a patient. 19.The suturing instrument of claim 15 wherein the needle carrier defines alumen for sequentially receiving each of the at least two needles. 20.The suturing instrument of claim 15 wherein the elongate body memberincludes a bend.
 21. The suturing instrument of claim 15 wherein theelongate body member includes two bends.
 22. The suturing instrument ofclaim 15 wherein the distal portion of the elongate body member isrotatable relative to a remainder of the elongate body member.